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Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

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ClinicalTrials.gov Identifier: NCT00676130
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : August 14, 2012
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cellulitis
Interventions Drug: trimethoprim-sulfamethoxazole
Drug: Cephalexin
Enrollment 153

Recruitment Details We enrolled generally-healthy subjects with uncomplicated acute cellulitis from 6/2007 to 12/2011. Eligible subjects were adults and children presenting to EDs of 3 teaching hospitals in Boston, MA.
Pre-assignment Details Each subject was assigned randomly to a treatment group by the institutions’ research pharmacies. The research pharmacies had no knowledge of subjects’ clinical characteristics. Treating (non-research) clinicians, research clinicians, coordinators, and subjects had no knowledge of the randomization sequence.
Arm/Group Title Trimethoprim-sulfamethoxazole Placebo
Hide Arm/Group Description Cephalexin plus trimethoprim-sulfamethoxazole Cephalexin plus placebo
Period Title: Overall Study
Started 76 77
Completed 73 73
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             0             1
Found ineligible             3             2
Withdrawal by Subject             0             1
Arm/Group Title Trimethoprim-sulfamethoxazole Placebo Total
Hide Arm/Group Description Cephalexin plus trimethoprim-sulfamethoxazole Cephalexin plus placebo Total of all reporting groups
Overall Number of Baseline Participants 76 77 153
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 153 participants
<=18 years
3
   3.9%
5
   6.5%
8
   5.2%
Between 18 and 65 years
68
  89.5%
69
  89.6%
137
  89.5%
>=65 years
5
   6.6%
3
   3.9%
8
   5.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 77 participants 153 participants
37.03  (15.07) 32.43  (15.15) 34.71  (15.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 77 participants 153 participants
Female
39
  51.3%
36
  46.8%
75
  49.0%
Male
37
  48.7%
41
  53.2%
78
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 76 participants 77 participants 153 participants
76 77 153
1.Primary Outcome
Title Relative Efficacy
Hide Description

Proportion of subjects in each arm with successful treatment.

Treatment success was assessed by physician examination at 12 +/- 2 days. Non-success was defined as subsequent hospitalization, change in antibiotics, surgical or needle drainage of an abscess, or recurrence of infection within 30 days. Cure was defined as resolution of all symptoms other than mild residual erythema or edema. We confirmed the determination of cure by telephone interview and medical record review at 30 +/- 2 days.

Time Frame 12 +/- 2 days; 30 +/- 2 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 153 randomized subjects, 4 were randomized in error and did not receive study drug, 1 received two doses before it was discovered that he was ineligible, 1 was lost to follow up, and 1 withdrew voluntarily in the first few days after enrollment. This left 146 subjects for intent-to-treat analysis.
Arm/Group Title Trimethoprim-sulfamethoxazole Placebo
Hide Arm/Group Description:
Cephalexin plus trimethoprim-sulfamethoxazole
Cephalexin plus placebo
Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
62 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trimethoprim-sulfamethoxazole, Placebo
Comments The study was powered to detect a difference in cure rate of 98% in the intervention group vs. 85% in the control group, with 2-sided alpha 0.05. This would yield a number needed to treat of 7.7 for intervention vs. control, and required 144 subjects to achieve 80% power. No data were analyzed until study completion.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.7
Confidence Interval 95%
-9.3 to 15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression to Abscess
Hide Description Proportion of subjects in each arm with progression from cellulitis to abscess.
Time Frame 12 +/- 2 days, 30 days +/- 2 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Trimethoprim-sulfamethoxazole Placebo
Hide Arm/Group Description:
Cephalexin plus trimethoprim-sulfamethoxazole
Cephalexin plus placebo
Overall Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: participants
5 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Trimethoprim-sulfamethoxazole, Placebo
Comments We assessed the rate of progression to abscess in the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-6.5 to 6.3
Estimation Comments [Not Specified]
Time Frame 30 days, assessed via telephone contact, in-person visit, and medical record review.
Adverse Event Reporting Description Serious adverse events were considered to be those resulting in hospital admission.
 
Arm/Group Title Trimethoprim-sulfamethoxazole Placebo
Hide Arm/Group Description Cephalexin plus trimethoprim-sulfamethoxazole Cephalexin plus placebo
All-Cause Mortality
Trimethoprim-sulfamethoxazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Trimethoprim-sulfamethoxazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/73 (0.00%)      1/73 (1.37%)    
Gastrointestinal disorders     
Clostridium difficile colitis   0/73 (0.00%)  0 1/73 (1.37%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trimethoprim-sulfamethoxazole Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/73 (49.32%)      39/73 (53.42%)    
Gastrointestinal disorders     
Diarrhea   21/73 (28.77%)  25/73 (34.25%) 
Vomiting   5/73 (6.85%)  8/73 (10.96%) 
Nausea *  15/73 (20.55%)  13/73 (17.81%) 
Skin and subcutaneous tissue disorders     
Pruritis *  5/73 (6.85%)  3/73 (4.11%) 
Rash   5/73 (6.85%)  3/73 (4.11%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Daniel J. Pallin, MD, MPH
Organization: Brigham and Women's Hospital
Phone: 617-525-6614
Responsible Party: Daniel Jay Pallin, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00676130     History of Changes
Other Study ID Numbers: 2007P000414
F8349839
First Submitted: December 28, 2007
First Posted: May 12, 2008
Results First Submitted: July 3, 2012
Results First Posted: August 14, 2012
Last Update Posted: August 14, 2012